Optimize Process Validation Package

WEBINAR

As you advance your biologic drug towards commercial manufacturing and Marketing Authorisation Application (MAA), you need to start process validation activities, and in many cases, you have limited information and data available from the clinical stage. Quality By Design (QBD) has become the gold standard to ensure quality risk management throughout the product life cycle. Statistical Design of Experiment is the method of choice to achieve this goal but finding the right balance between a large number of experiments and speed without sacrificing quality is not always easy. Actually, there are opportunities for more flexible approaches that focus on the critical process parameters and an appropriate process validation strategy.

In this webinar, you will learn:

• How outsourcing to a CDMO partner in a late stage will increase flexibility and speed
• How a risk-based approach can help you optimize your process validation strategy
• How we have implemented a risk-based approach for our clients